Modified Early Warning Score (MEWS) and Quick Sequential Organ Failure Assessment (qSOFA) in the Emergency Room

• Sponsor: St. Martin De Porress Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05584098
• Collaborator: (none)
• Enrollment: 5,000
• Arm: 1
• Anticipated Duration (Months): 4.9

Study Details

Study Description

Brief Summary

In the development of sepsis treatment of recent years, the demand for medical manpower has increased significantly when patients with sepsis appear because of the expansion of medical care demand and shortened response time related to sepsis Due to the shortage of manpower, a more simple and easy-to-operate inspection method is adopted and artificial intelligence technology is used to assist in the evaluation.

The applicability of physiological indicators MEWS and qSOFA as sepsis screening tools in emergency department (ED) and predicting sepsis outcome in the emergency department. When patients with sepsis appear, artificial intelligence technology is used to remind the physicians to respond and administer drugs as soon as possible.

This is a single-center retrospective study of a group of patients admitted to the emergency department. The medical records were reviewed, mainly based on the hospital site records and the existing vital signs of the patients. Attended a hospital emergency room between January 2020 and December 2022. Physiological numerical indicators MEWS and qSOFA were all scored to understand the distribution of sepsis.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Other: qSOFA and MEWS	N/A

Detailed Description

1. A single-center retrospective study of a cohort of patients admitted to the emergency department

2. To see a doctor in the emergency department of the hospital between January 2020 and December 2022, review their medical records, and focus on the hospital's on-site records and the existing patient's vital signs.

3. The physiological indicators MEWS and qSOFA were scored to understand the distribution of sepsis.

4. Remind the doctor when a suspected sepsis patient appears under level 5 triage and use artificial intelligence technology to assist

5. This study will explore the specific improvement practices and effects of improving the response of patients with sepsis when they see a doctor

6. To analyze and evaluate the economics and benefits of this operation mode, improve the accuracy of emergency inspection of sepsis patients and improve the rationality of hospital manpower deployment

7. Scheduled progress of the plan: Patients who visited the emergency department of the hospital between January 2020 and December 2022 were included in this study under investigation. This is a retrospective study, and patients are required to undergo necessary examinations according to their own conditions, without any interference from the study

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 5000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: In a cross-sectional study, the investigator measures the outcome and the exposures in the study participants at the same time.In a cross-sectional study, the investigator measures the outcome and the exposures in the study participants at the same time.
• Masking: None (Open Label)
• Masking Description: Mask all identified labels in all raw data
• Primary Purpose: Screening
• Official Title: Modified Early Warning Score (MEWS) and Quick Sequential Organ Failure Assessment (qSOFA) to Predict the Occurrence of Sepsis in the Emergency Room
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: qSOFA and MEWS Modified Early Warning Score(MEWS) and quick Sequential Organ Failure Assessment(qSOFA) are used in prediction of occurrence of sepsis	Other: qSOFA and MEWS; qSOFA and MEWS used in emergency medicine department could be helpful in the identification of the occurrence of sepsis

Outcome Measures

Primary Outcome Measures

1. qSOFA used in emergency medicine department [From date of randomization until the date of first documented progression assessed up to 36 months]

   The qSOFA score is a simple score consisting of three items: respiratory rate (RR) ≥ 22 breaths per minute, altered mentation (Glasgow Coma Scale [GCS] < 15), and systolic blood pressure (SBP) < 100 mmHg and lowest score is 1 and highest is 3. The more score will show more severe disease. MEWS score:Description Risk of death or ICU admission <3: patient in a stable condition, 3-4: Signs of respiratory failure. Consider higher level of care, ≥5: Patient in a critical condition. Higher level of care recommended

2. Modified Early Warning Score(MEWS) which quickly determine whether a particular patient needs increased medical attention [From date of randomization until the date of first documented progression assessed up to 36 months]

   MEWS score = Systolic blood pressure + Heart rate + Urine output + Respiratory rate + Temperature + AVPU. The lowest score is 0 and highest score is 14. The more score will show more severe disease. MEWS score:Description Risk of death or ICU admission <3: patient in a stable condition, 3-4: Signs of respiratory failure. Consider higher level of care, ≥5: Patient in a critical condition. Higher level of care recommended

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• This is a single-center retrospective study of a group of patients admitted to the emergency department.

Exclusion Criteria:

• Patients with incomplete treatment clinical data, lack of information in medical records, trauma patients

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• St. Martin De Porress Hospital

Investigators

• Principal Investigator: Chia-Hsi Chen, MD, Emergency Medicine Department of St. Martin De Porres Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chia-hsi Chen, attending physician,emergency medicine department, St. Martin De Porress Hospital
• ClinicalTrials.gov Identifier: NCT05584098
• Other Study ID Numbers: 21B-004
• First Posted: Oct 18, 2022
• Last Update Posted: Oct 20, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chia-hsi Chen, attending physician,emergency medicine department, St. Martin De Porress Hospital: Sepsis; Modified Early Warning Score(MEWS); quick Sequential Organ Failure Assessment(qSOFA); emergency Medicine
• Additional relevant MeSH terms: Sepsis; Emergencies

Study Results

No Results Posted as of Oct 20, 2022